Oct 12, 2022. ABRF 2022, Palm Springs, California ABRF 2021, Virtual Annual Meeting (Click here to see a meeting summary from Instrument Business Outlook!) Juergen Metzger, Product Specialist, Sartorius North America Inc.. Design & Customization of Lubricants and Related Materials to Meet the Diverse Needs of the Parenteral Drug Delivery Industry Michael de la Torre, CEO, Redica Systems. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. DP and Critical Materials, Bristol-Myers Squibb. CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. Guestroom rates are subject to State and Local taxes. James L. Vesper, PhD, MPH, Director, Learning Solutions, ValSource, Inc. 16:20 | Is Regulatory Intelligence Compatible with an Effective QMS? New Materials and Advanced Manufacturing Techniques of Films for Sterile Injectables Processing and Finished Dosage Form Through a Re-engineered Supply Chain Manager Strategic Studies & Analytical Lifecyle, West Pharmaceutical Services, Inc. Dye Ingress for Container Closure Integrity Testing (CCIT) of Pre-Filled Syringes - Optimize or Decommission? A Novel Device for Reconstitution and Administration Other discounts cannot be applied. Tel: +1 (301) 656-5900, Am Borsigturm 60 This session will explain how to get the best internal data from personnel, will reimagine todays regulatory intelligence process from start to finish, and will make the case for disrupting the status quo by driving to a single, globally harmonized Quality Management System. Dr. Forster will also elaborate on how to leverage insights derived from other industries. Drug-Device Combination Products (DDCP) Development and Lifecycle Planning Please call 214 849 6831 for bus information. May 15-17, 2022. Paul Draper, MEng, Senior Sector Manager, Medical & Scientific, DCA Design International, 13:50 | Development of Digital Surround for Connected Devices: Real-Life Case Study Frank Van Reeth, MS, Director IHD-Ophtha Portfolio Mgmt Global Device & Packaging Development, Novartis International AG . David L. Jones, PhD, Director of Industry Affairs, Rapid Micro Biosystems. This session will explore various opportunities for making home drug delivery a reality from smart delivery devices for the home setting, enabling primary containers for single use administration to patient training and on-boarding solutions specifically designed for at-home use. Moderator: Brigitte Reutter-Haerle, Vice President Product Management & Marketing, Vetter, 10:45 | Primary Container Sequence for On-body Large Volume Injectors: From Vial to Pre-filled Cartridge Bjarne Srensen, Director, Front End Innovation, Phillips-Medisize, 07:15 08:15 | Concurrent Breakfast Sessions, Breakfast 1: Silicone-Free Solutions for Pre-filled Syringes Shelley M. Preslar, MBA, President and COO, Azzur Training Center Raleigh LLCand Co-Chair, 2022 PDA Annual Meeting, 13:30 | Jeffrey C. Baker, PhD, Senior Fellow, National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL). Andrea M. Pisa, MSc, MA, Head of Human Factors, Crux Product Design Ltd, 16:25 | Rethinking Connectivity: The Data-innovation Loop 13:00 15:00 | P1: Moving Forward from Abrupt Regulatory Challenges to the New Normal Meet us and other delegates for 2 days of stimulating presentations, interesting booths (find us at #921) and exciting networking opportunities! 13:00 | Container Closure Integrity Testing and Finishing 11:05 | Industry Working Group Collaboration: Speedbump Navigation during the Implementation of a Bio-Fluorescent Particle Counting System Lisa Dick, PhD, Senior Scientist, Kindeva Drug Delivery, B3: Human Factors: Your Roadmap to a Successful Submission PDA's Universe of Pre-filled Syringes and Injection Devices Conference Moderator: Amanda M. McFarland, MS, Senior Consultant, ValSource, Inc. Aseptic process simulation (APS) has been identified as one of the key aspects of aseptic process control and monitoring. Finola Austin, MScErg, Human Factors Engineering Manager, Owen Mumford. John Burke, Senior Consultant, Team Consulting, Large Volume Subcutaneous Injection: Feasibility and Acceptability Patterns Across a Sequence of Translational Studies 16:00 | Challenges and Opportunities in Implementing Next-Generation Technologies for Drug Product Development and Manufacturing Lauren Guimond, MS, Analytical Sciences Manager, SHL Medical, 14:10 | Moving Patient Training from Clinical to Home Settings This session will focus on technologies designed for therapeutic outcomes and data capture across the manufacturing process up until the medicine is delivered to the patient. HowTo: Using the Palm PDA in 2022 | by Dmitrii Eliuseev - Medium Individuals will be responsible for payment of their own cancellation fees. The cancellation policy is 3 days in advance of arrival date, unless otherwise specified on your reservation information. 10:45 | Case Study: How to Bridge the Differences Between a Clinical Device Used in Pivotal Clinical Studies and a Commercial Device Christopher Andreola, PhD, Sr Product & Innovation Manager - MEDICAL, Nye Lubricants, Inc. (FUCHS Group), Development of a Submucosal Injection Device for an Oral Biotherapeutic Delivery System Maik W. Jornitz, MSEng, CEO, G-CON Manufacturing, Inc. 11:05 | A 3P Model to Sustainable cGMP Cleaning George Bernstein, PhD, ChE, Managing Principal, Double Dragon Consulting, 16:40 | Implementation of VR and AR Tools for Error Reduction Dallas, TX Finally, we will learn about regulatory considerations. 14:10 | Article 117 of the EU Medical Device Regulation: Regulatory Best Practices and Opportunities Associated with Notified Body Opinion (NBOp) The aim of this conference is to provide the latest information and to . Amtrak: Connected to Hyatt Regency Dallas by way of underground walkway to Union Station. PDA Universe of Pre-filled Syringes and Injection Devices Conference 2022 Paul Cashen, MSc, Senior Bioprocess Specialist, Pall Corporation. The 2022 PDA Annex 1 Workshops highlight critical changes in the new regulation and include interactive sessions to provide attendees with a clear understanding of and means to implement all the requirements of the rule. The first speaker will provide experimental results obtained from comparing both glass and polymer silicone-free container closure systems in terms of functional performance and drug stability. The methodologies within the area of microbial growth detection and monitoring are constantly evolving based on the innovative technologies throughout the industry. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. [emailprotected], Tel: +49 (0) 30 43 655 08-10 Surveillance is another matter that will be addressed as it relates to zoonotic infectious diseases and emergence of new variants. (NRCM), Senior Consultant Microbiology, ValSource, Inc. 15:20 | Contamination Control Strategy Development 2022 PDA Annual Meeting Weve come together to create effective tools to fight a global pandemic. As the development and production of vaccines need to be prepared for the future, participants will also learn how this can be achieved through implementing end-to-end digitization. 15:55 | Michael Brothers, PhD, Technical Program Manager/Principal Scientist, UES, Inc. 17:00 18:30 | Grand Opening Celebration in Exhibit Hall. There is an enormous amount of data being collected today, but what does it all mean? Esther Foo, PhD, Senior Scientist, Merck & Co., Inc. 11:25 |Human Factors (HF) Hot Potatoes: Addressing Key HF Topics in the Design, Development, and Successful Marketing Approval of Drug-Device Combination Products Compared to it, Palm TX looks much better it was . Steven R. Kaufman, MBA, Vice President, Drug Delivery Systems, Stevanato Group, 11:15 | Cross-Industry Collaboration as Enabler for the Rapid and Successful Development of New Injection Devices: A Patch Injector Case Study Jeremy Hemingway, MS, PE, Senior Associate, Stress Engineering Services, Inc. C2: Tools and Approaches for Improving the Sustainability of Devices and Their Supply Chain Hal Baseman, MBA, Chief Operating Officer, ValSource Inc. 08:20 | Qualification and Training Learn about opportunities and benefits. HLPA has written an open letter to Rt Hon Simon Clarke MP and Rt Hon Branden Lewis MP. Moderator: Kristin N. Valente, PhD, Director, Vaccine Technical Operations, Merck & Co., Inc. Greyhound: The nearest Greyhound station is located at 205 S Lamar St. Attendees will discuss the implementation challenges, and what can be done to meet those challenges, associated with the topics presented in P4: Equipment, Technology, and Utilities. Set against a backdrop of swaying palm trees and the majestic San Jacinto Mountains, our Coachella Valley hotel captures the essence of desert living. Attendees will discuss the implementation challenges, and what can be done to meet those challenges, associated with the topics presented in P1: Overview of and Revision Process for Annex 1 and P2: Scope, Principles, and Pharmaceutical Quality Systems. The pandemic experience typified the need to be prepared for serious unanticipated events. Visit us at booth 113. Get in touch with Aenova and contact us here ! For example, in viral vector manufacturing, challenges arise due to the constant balance between processing small batch sizes and ensuring the valuable product makes it into the freezer within the time that the product is still stable. Moderator: Shelley M. Preslar, MBA, President and COO, Azzur Training Center Raleigh LLC, 16:00 | Blended Training Approach to Minimize Human Error in Biopharmaceutical Manufacturing Peter Holst, Co-Founder and CEO, FPrin, LLC. It is a 2 day event organised by Parenteral Drug Association (PDA) and will conclude on 19-Oct-2022. Routine monitoring of personnel ensures that the qualified personnel are following the established procedures and that they can meet the strict gowning cleanliness requirements during normal operations. Individuals will be responsible for payment of their own cancellation fees. GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. Moderator: Amanda M. McFarland, MS, Senior Consultant, ValSource, Inc. [emailprotected], Tel: +49 (0) 30 43 655 08-10 08:00 10:00 | P1: Fast Track Vaccine Development and the Benefits of Platforms A block of rooms has been reserved for meeting participants at the Courtyard Palm Springs Hotel. In and out privileges for hotel guests only. Moderator: Diane M. Paskiet, MS, Director of Scientific Affairs, West Pharmaceutical Services, Inc. Statements claiming to offer our attendee lists are fraudulent. Guangli Hu, PhD, Principal Scientist, Merck & Co., Inc. Characterizing Silicone Oil Leachates and Its Impact on Biologic Drug Product in Prefilled Syringes Innovative options for audits and inspections have become increasingly important due to the recent challenges brought about due to the pandemic. Donald C. Singer, MA, Senior Microbiology Technical Consultant, North America, Ecolab Life Sciences, 13:40 | Barrier Technologies: RABS and Isolators, Glove Integrity, Robotics, Decontamination Leilei Zhang, Associate Principal Scientist,Merck & Co., Inc. Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Discuss the market benefits of pre-filled syringes and injection devices; Identify critical attributes of end-user friendly devices; Explain how innovation is helping patients to have a positive experience in managing their therapies and assuring compliance to dose regime; Summarize manufacturing requirements of pre-filled syringes, injection devices, safety devices, and final drug/device combo products; Discuss quality standards, regulatory and compliance concerns; List insights through case studies presented by industry experts; and. 18/10/2022 - 19/10/2022 Palm Springs, CA. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Jeffrey Givand, PhD, Co-Chair, PDA Universe of Pre-filled Syringes and Injection Devices Conference and Executive Director, Device and Combination Product Development, Merck & Co., Inc. No credits will be given for cancellation requests received less than 30 days before the event. 13:00 14:15 | P3: Premises and Barrier Systems Radish Lot, 8-24 hours | $19 Jerry L. Chapman, MBA, Senior GMP Quality Expert, Redica Systems. After the event, Agle will sign books and the Modernism Week 2022 commemorative posters he designed, pictured above. Sheba S. Zaman, Head of Product Specialists and Training Services, Novatek. The Hyatt Regency Dallas is located at 300 Reunion Boulevard, Dallas, TX 75207. IG2: Process Validation and Lyophilization. Taking place in Palm Springs, CA, the Conference will dive into interactive sessions and multiple tracks that will address innovation and regulatory trends in the universe of application device technology and explore what's next for the future of this field. 48 hours| $26 10:00 | Using Quality Risk Management to Enable the Contamination Control Strategy By eliminating the need for silicone in both the barrel and . Palm Springs Convention Center. D1: Building Back Better: Innovative Options for Audits and Inspections Metals and mining is in our DNA. Valet Parking The aim of the 21st Century Cures Act is to enable the production of safe and effective medicines to improve patient experiences and outcomes. Reservations must be secured by Friday, 04 March 2022. Video, photo, and audio recordings are prohibited at all PDA events. Christopher Weikart, PhD, Chief Scientist, SiO2, 16:05 | Pushing the Boundaries for Glass Prefilled Syringes: Container Closure Integrity, Stability and Performance at -80C Jason Kerr, MBS, MBA, Senior GXP Specialist, Redica Systems and Co-Chair, 2022 PDA Annual Meeting Unfortunately, emails are circulating that offer to sell attendee lists for many of PDAs conferences and events. Talks will highlight Annex 1 focal points including contamination control strategy, quality risk management, and quality culture, including a discussion on the importance of human factors: knowledge, attitude, and experience. Accommodation requests must be made no later than 18 March 2022. Dive into exciting interactive sessions and tracks especially designed for manufacturing leaders, technical experts/scientists, and early career professionals. Director Program Management, BD, 07:35 | Making PFS Smart: Challenges and Opportunities of RFID-Equipped Pre-Filled Syringes 15:30 | Benjamin Borgo, MS, PhD, MBA, Head of Portfolio Management and Product Development, MilliporeSigma. 10:45 | Device and Drug Companies on the Same Path: A Collaborative Approach to Developing a Combination Product (This applies in particular to costs for submitting documents by courier.). Characterizations of Plunger Stopper Movement 13507 - Berlin, Germany Moderator: Josh Gonzalez, Chief Commercial Officer, SHL Medical. Juan Cheng, Principal Scientist, Merck & Co., Inc. Valet Parking, operated by PMSI, is available at hotel entrance. Website| Reservations Link. In and out privileges for overnight guests only, operated by PMSI. This session will introduce some of the more intriguing topics covered and expanded in the revised Annex 1, which were selected based on input from the sterile product manufacturing community, as noted during prior meetings and discussions. Patrick Grandt, Medical Device Engineer, Genentech, Inc. A Packaging Platform for Pre-Filled Syringes and Self-Injection Devices; How Unit-Level Compliance Can Improve Treatment Outcomes Chris Hurlstone, MA, Director of Engineering, Team Consulting, 15:00 15:45 | Refreshment Break, Tech Talks, and Poster Presentations in the Exhibit Hall, A2: Digital Health Solutions: Focus on the End User If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. This Conference will focus on the theme to Level Up: Agility in the New Normal! Anne Marie Dixon-Heathman, MBA, President, Cleanroom Management Associates, Inc. 11:25 | Changing the Face of Contamination Control using Physics PDA will not be responsible for any costs incurred by registrants due to cancellation. You must have this confirmation letter to be considered enrolled in a PDA event. D3:Data Integrity Trends, Patterns, and Insights 16:00 | The Role of Psychological Safety in Reducing Human Error and Advancing Quality Management Maturity Connecting People, Science and Regulation. The session will include a discussion on the key opportunities and challenges ahead, as well as how biopharma representatives should evaluate investment options in this future changing market. Ontario International airport (ONT) is 70 miles from Hotel. 07:15 | A Case Study: Evaluation of Silicone Free Syringes Suitable for Silicone-oil Sensitive Molecules and Compatible with Existing Medical Device Platforms Frederic B. Ayers, Research Scientist, Eli Lilly and Company, 10:40 | Filtration and Pre-Use Post Sterilization Integrity Testing Reto Jost, MSc, Innovation & Business Development Director, Ypsomed AG, 12:15 13:30 | Networking Lunch and Tech Talks in the Exhibit Hall, A1: Connected Devices and Digital Ecosystems This airport is serviced by numerous carriers. Robert R. Nesbitt, Director, Portfolio Strategy, AbbVie, Inc. 13:50 | The Entire ISO 11608 Series Standards Are All New - Now What? 15:30 | Water Systems and Other Critical Utilities Cancellation requests must be emailed to [emailprotected]. The Interest Group will be discussing the recently launched a survey on process validation approaches. Copyright Parenteral Drug Association. Updates on ISO standards will be presented, as well as discussing ramifications and the path ahead. Fax: +49 30 436 55 08-66, 4350 East West Highway, Suite 110 IG4: Visual Inspection Note: PDA does not sell its exhibitor or attendee lists, and no third-party is authorized to distribute or sell any lists related to our events. The next talk will highlight specific challenges getting these silicone-free rubber components processed on standard fill and finish lines and solutions developed. 13:00 | Welcome from PDA Leadership and the Program Planning Committee Co-Chairs What if companies could work together to overcome hesitation and adopt new technologies in commercial processes? This workshop will provide an opportunity for attendees to hear from industry experts and regulators, and open discussions with their peers challenges and best practices. All rights reserved. Overnight Guests |$32 + tax PDA Conference October 18th-19th 2022 | Oval Medical Technologies If there's a child protection conference for your child Tel: +65 64965504 Marcia C. Baroni, MBA, , VP Quality Operations, Emergent BioSolutions, 08:40 | Gowning, Personnel Monitoring, and Beyond Moderator: Shelley M. Preslar, MBA, President and COO, Azzur Training Center Raleigh LLC. Video, photo, and audio recordings are prohibited at all PDA events. 16:25 | Evaluation of Pre-filled Syringe Container Closure Integrity at Deep Cold Storage Conditions Using a Combination of Predictive Modeling and Empirical Testing Moderator: Maggie Reiff, VP,Development, ApiJect Corp, 10:45 | Applying Human Factors Engineering for Successful FDA Submissions of Injection Devices Shear Damped Auto-injector a Novel Approach to Mitigating the Risks and Difficulties Associated with Injecting High-Viscosity & Emergency Use Pharmaceuticals Please contact us if you are entiteld to receive a discount. 2022 PDA Universe of pre-filled Syringes and Injection Devices Mark Zimmerman, Business Development, Kimball Electronics, How to Partner for Wins She will verify your status and register you. Moderator: Jason Kerr, MBS, MBA, Senior GXP Specialist, Redica Systems. Herve Soukiassian, Ass. The 2022 PDA Universe of Pre-Filled Syringes and Injection Devices Conference will continue to build on the reputation of past events while bringing to light the latest advances in the field.This conference will explore the future of pharmaceutical devices, such as rapid technological advances, that will push the industry ahead while bringing . Seungyil Yoon, PhD, Vice President, Drug Product Development, Samsung, 11:25 | The Top Challenges (and Solutions) to Develop and Commercialize Intradermal Drug Delivery Devices We will conclude by reviewing the shared vision from a cross-industry collaboration. The trend to move therapies to the home setting has been known for some time but the pandemic has accelerated and changed drug formulation strategies. Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. IG8: Facilities and Engineering The biopharmaceutical industry has a strong track record of regulatory submissions and approvals. PDA Universe of Pre-Filled Syringes and Injection Devices Conference is starting soon and we are excited to be a sponsor of this event! The 2022 PDA Universe of Pre-Filled Syringes and Injection Devices Conference will continue to build on the reputation of past events while bringing to light the latest advances in the field. PDA Announces Nearly 100 Exhibitors at the 19th Universe of Pre-Filled Amy Hartl, PhD, Director of Process Development, SHL Medical BobChaplinsky, Head of Quality Management Systems, UCB Pharma SA Mihaela Simianu, PhD, Executive Director, Merck & Co., Inc. D2: Regulatory Intelligence in the Digital Age: Friend or Foe? Phone: +1 (214) 651-1234. Soeren Miethke, MSc, Senior Scientist PPMD, CSL Behring AG, 07:35 | A Case Study in Fill-and-Finish Machinability of Silicone-free Pre-filled Syringe Components Amir Genosar, CEO, Aktiv Pharma Group, Practical Implementations of the Critical Parameters Design and Management (CPDM) Process in Emergency-Use Injector Programs The agenda is available! James M. Fries, CEO, Rx-360, 12:15 13:45 | Networking Luncheon, Poster Presentations, and Tech Talks in Exhibit Hall. Copyright Parenteral Drug Association. 10:45 | Data Integrity Trends in 2021 : New Technology Facilitating Process-Product Communication The group rate at all hotels is $199 for single or double occupancy. These emails are sent by scammers. 16:40 | What If Sterile Product Processing Equipment Could Talk? The 2022 PDA Annual Meeting promises to have something for everyone! Vaishali Shah, MS, Head of Quality Systems and Compliance, Kite Pharma, A Gilead Company Diego Zurbriggen, Sr. This is the final workshop in a series that PDA has hosted in 2022 to educate and help the industry implement the new Annex 1 revision. Taxi fares from DFW are approximately $45-50 one way, not including tip. IG6: Microbiology/ Environmental Monitoring Patient-focused drug development is described in regulatory guidance as a multifaceted approach to link patient information with the product lifecycle.
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